Pulmonary Nodule, SolitaryNCT03591445
Is Bronchoscopy Necessary in the Preoperative Workup of GGO Lung Cancer?(ECTOP-1005)
A study testing Flexible Bronchoscopy in people with Pulmonary Nodule, Solitary, run by Fudan University at 1 site in China.
Trial summary
This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1005). It aims to evaluate the role of flexible bronchoscopy in the pre-operative workup of ground glass opacity featured lung cancer. All enrolled patients receive the flexible bronchoscopy examination before surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Nodule, Solitary
- What is being tested?
- Flexible Bronchoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 615 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ground glass opacity pulmonary nodule diagnosed by thoracic CT
- karnofsky performance status ≥60
- No surgical contraindication
- Patients who sign the informed consent
- Pre-operation clinical stage :T1abcN0M0
- Age:18-80 years old
Who cannot join
- Central lung tumor diagnosed by CT
- Tracheal or bronchus deformity diagnosed by CT
- Tracheal or bronchus disease history
- Severe smoking history （smoking index ≥400/year）
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Bronchoscopy Necessary in the Preoperative Workup of Ground Glass Opacity Featured Lung Cancer?
This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1005). It aims to evaluate the role of flexible bronchoscopy in the pre-operative workup of ground glass opacity featured lung cancer. All enrolled patients receive the flexible bronchoscopy examination before surgery. Investigators observe the intra-bronchial findings of bronchoscopy and the impact of these findings on established surgical plan.
Read the detailed description
The appropriateness of routine use of bronchoscopy in the operative workup of a solitary pulmonary nodule（SPN） is debatable. Options expressed in the literature vary from routine preoperative bronchoscopy having no role in obtaining tissue diagnosis in small SPNs to it begin very useful in determining underlying etiology and surgical strategy. The American College of Chest Physicians（ACCP）guidelines recommend bronchoscopy only if air-bronchogram is present or if operator has expertise with newer guided techniques. Previous study showed that bronchoscopy is not indicated in SPNs that present with ground-glass opacity on CT. The purpose of this analysis is to define that role by examining in GGO patients （1）intra-bronchial findings （2）impact of these findings on established surgical plan.
- Conditions
- Pulmonary Nodule, Solitary
- Being tested
- Flexible Bronchoscopy
- Medical subject headings
- Solitary Pulmonary Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible BronchoscopyDevice
Flexible Bronchoscopy
| Study group | Role | What they receive |
|---|---|---|
| Experimental：Bronchoscopy | Experimental | Patients with ground glass opacity featured lung cancer who are candidates for surgeyr received the bronchoscopy examination before surgery. Receives: Device: Flexible Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate that established surgical plan is changed by positive intra-bronchial findings
The number of patients （surgical plan is changed by positive intra-bronchial findings） /Total number of patients
Measured: about 14 days
Secondary outcomes (1)
rate of positive intra-bronchial findings
the number of patients with positive intra-bronchial findings / total number of patients
Measured: about 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start6 Nov 2018
- Primary completion30 Nov 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Nodule, SolitaryStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- We hypothesized incidence rate that bronchoscopic findings would have changed the rate of established surgical plans as less than 2.0% (P0), then preoperative bronchoscopy examination would have limited impact on the surgical plan for GGO featured lung cancer; If bronchoscopic findings would have changed the rate of established surgical plans as more than 4.0% (P1), then bronchoscopy examination would be regarded as one routine preoperative work-up. Null hypothesis: H0: P≤P0; Alternative hypothesis: HA: P ≥ P1. α = 0.05, 1-β = 0.9. Using Simon's two-stage approach, the first phase enrolled 612 patients. If ≥18 patients supported the alternative hypothesis, they entered the second phase, otherwise the trial was terminated; the second phase enrolled 451 patients. If the patient number who eventually changes the surgical plan is ≤27, the null hypothesis is accepted, that preoperative bronchoscopy examination would be unnecessary for GGO featured lung cancer.
- Masking
- None (open label)
- Enrolment
- 615 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Cancer Hospital, Anhui Chest Hospital, Shanghai Zhongshan Hospital, Affiliated Hospital of Jiangnan University, Jilin Provincial Tumor Hospital, Guanxian Central Hospital of Shandong Province, The Third people's Hospital of Jieyang, Queen Mary Hospital, Hong Kong, Jiangdu people's hospital of Yangzhou Jiangsu Province
- Responsible party
- Principal investigator, Haiquan Chen, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591445
- Sponsor's protocol ID
- Fudan_bronchoscopy
- Status last verified
- Jul 2023
- First submitted
- 7 Jul 2018
- Last updated
- 20 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Bronchoscopy Necessary in the Preoperative Workup of Ground Glass Opacity Featured Lung Cancer?
- ClinicalTrials.gov ID
- NCT03591445
- Acronym / sponsor ID
- Fudan_bronchoscopy
- Conditions
- Pulmonary Nodule, Solitary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 615 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Henan Cancer Hospital, Anhui Chest Hospital, Shanghai Zhongshan Hospital, Affiliated Hospital of Jiangnan University, Jilin Provincial Tumor Hospital, Guanxian Central Hospital of Shandong Province, The Third people's Hospital of Jieyang, Queen Mary Hospital, Hong Kong, Jiangdu people's hospital of Yangzhou Jiangsu Province
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1005). It aims to evaluate the role of flexible bronchoscopy in the pre-operative workup of ground glass opacity featured lung cancer. All enrolled patients receive the flexible bronchoscopy examination before surgery. Investigators observe the intra-bronchial findings of bronchoscopy and the impact of these findings on established surgical plan.
Detailed description
The appropriateness of routine use of bronchoscopy in the operative workup of a solitary pulmonary nodule（SPN） is debatable. Options expressed in the literature vary from routine preoperative bronchoscopy having no role in obtaining tissue diagnosis in small SPNs to it begin very useful in determining underlying etiology and surgical strategy. The American College of Chest Physicians（ACCP）guidelines recommend bronchoscopy only if air-bronchogram is present or if operator has expertise with newer guided techniques. Previous study showed that bronchoscopy is not indicated in SPNs that present with ground-glass opacity on CT. The purpose of this analysis is to define that role by examining in GGO patients （1）intra-bronchial findings （2）impact of these findings on established surgical plan.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- We hypothesized incidence rate that bronchoscopic findings would have changed the rate of established surgical plans as less than 2.0% (P0), then preoperative bronchoscopy examination would have limited impact on the surgical plan for GGO featured lung cancer; If bronchoscopic findings would have changed the rate of established surgical plans as more than 4.0% (P1), then bronchoscopy examination would be regarded as one routine preoperative work-up. Null hypothesis: H0: P≤P0; Alternative hypothesis: HA: P ≥ P1. α = 0.05, 1-β = 0.9. Using Simon's two-stage approach, the first phase enrolled 612 patients. If ≥18 patients supported the alternative hypothesis, they entered the second phase, otherwise the trial was terminated; the second phase enrolled 451 patients. If the patient number who eventually changes the surgical plan is ≤27, the null hypothesis is accepted, that preoperative bronchoscopy examination would be unnecessary for GGO featured lung cancer.
| Arm | Type | Receives |
|---|---|---|
| Experimental：Bronchoscopy | Experimental | Device: Flexible BronchoscopyPatients with ground glass opacity featured lung cancer who are candidates for surgeyr received the bronchoscopy examination before surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ground glass opacity pulmonary nodule diagnosed by thoracic CT
- karnofsky performance status ≥60
- No surgical contraindication
- Patients who sign the informed consent
- Pre-operation clinical stage :T1abcN0M0
Key exclusion criteria (4 listed)
- Central lung tumor diagnosed by CT
- Tracheal or bronchus deformity diagnosed by CT
- Tracheal or bronchus disease history
- Severe smoking history （smoking index ≥400/year）
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flexible BronchoscopyFlexible Bronchoscopy | Device | Experimental：Bronchoscopy |
Primary outcome
Incidence rate that established surgical plan is changed by positive intra-bronchial findings
Time frame: about 14 days
The number of patients （surgical plan is changed by positive intra-bronchial findings） /Total number of patients
1 secondary outcome
rate of positive intra-bronchial findings
Time frame: about 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexible Bronchoscopy in people with Pulmonary Nodule, Solitary, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate that established surgical plan is changed by positive intra-bronchial findings (time frame: about 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.